Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025
USA
1. Guidance on: Quality Management System Information for Certain Premarket Submission Reviews
The guidance highlights the importance of submission of comprehensive, risk-based QMS documentation...
CDSCO India, EU MDR, FDA guidance, Global Regulatory News, MDA Malaysia, Medical Device Compliance, Medical Device Regulations, QMS, SaMD